MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVL12060

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2022).

Event Description

It was reported that after stent placement, device allegedly difficult to remove.It was further reported that the inner shaft allegedly broke.Reportedly, the device and the guidewire were removed together.There was no reported patient injury.

Event Description

It was reported that during removal of the device after a stent placement to treat iliac stenosis, strong resistance was felt on retracting the device through the guide wire and the inner shaft allegedly broke off.It was further reported that the device and the guide wire were removed together.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation.The inner catheter was protruding with a broken piece returned as part of the sample.The breakage site seems frayed which is considered to have resulted from the difficulty to remove the delivery system over the guidewire.The guiding tube connector was detached from the oval handle.In this case, it was noted that a device compatible guidewire was used, and the lesion was predilated.A detachment of the guiding tube from the oval handle was equally found during sample evaluation, which may have resulted in inadequate flushing of the delivery system.However, there was no report of difficulties during flushing.Based on the returned sample analysis, inner catheter break is confirmed.It is reasonably suggested that the break is related to the reported difficulties to remove the delivery system over the guidewire.However, a definite root cause of the reported issue cannot be identified.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use (ifu) sufficiently address the potential risks.The instructions for use states: "should unusual resistance be felt at any time during the procedure, the entire system (guidewire, introducer sheath and delivery system) should be removed as a single unit." regarding preparation of the procedure and potential contributing factors the instructions for use states that "the 6fr delivery system requires a minimum 6f introducer sheath.(¿) the catheter tip is tapered to accommodate a 0.035¿(0.89 mm) guidewire." and "prior to inserting the delivery catheter over the guidewire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter." h10: (expiry date: 05/2022).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12670365
• MDR Text Key: 277699606
• Report Number: 9681442-2021-00562
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146503
• UDI-Public: (01)00801741146503
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVL12060
• Device Lot Number: ANDS2667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1